Director, Clinical Development

Location
01752, Marlborough
Posted
May 23, 2019
Discipline
Science/R&D, Laboratory
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

Description

Sunovion Pharmaceuticals is looking for a Director, Clinical Development (Psychiatry) to join our R&D Organization in Fort Lee, NJ.

This individual will contribute to the design and execution of all aspects of the clinical development plan for multiple compounds/programs within the Psychiatry therapeutic area.

Essential Functions:

  • Contributes to the preparation of clinical protocols, Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards.
  • Contributes to data analysis planning and interpretation of clinical trial results, and the writing of Clinical Study Reports (CSRs).
  • Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting.
  • Contributes to developing clinical components of NDAs, sNDAs, MAAs and other regulatory filing documents.
  • Contributes to company responses to Health Authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally.
  • Contributes to clinical responses to Health Authority queries.
  • Contributes to the development of presentation materials for Health Authority Meetings, Scientific Advisory Board meetings, national and international scientific meetings, and investigator meetings.